Brachytherapy fiducial needle fixation system

ABSTRACT

A mechanism facilitates the insertion of radioactive sources/source strands into soft tissue, such as breast tissue, that improves the reproducibility of the procedure and ensures that the sources are reliably and consistently inserted in an exact position per a patient prescription treatment plan from patient to patient as well as improve the ease-of-use of the device and procedure.

PRIORITY CLAIMS/RELATED APPLICATIONS

This application claims priority under 35 USC 120 and is a continuationpatent application of U.S. patent application Ser. No. 14/313,978, filedJun. 24, 2014 and entitled “Brachytherapy Fiducial Needle FixationSystem And Method” which in turn claims priority under 35 USC 120 and121 and is a divisional patent application of U.S. patent applicationSer. No. 12/427,667, filed on Apr. 21, 2009 and entitled “BrachytherapyFiducial Needle Fixation System and Method”, the entirety of all ofwhich are incorporated herein by reference.

FIELD

The disclosure relates generally to a mechanism and method for radiationoncology.

BACKGROUND

When women are treated for breast cancer (which is the most commonlydiagnosed cancer in women), they can opt for a mastectomy (completeremoval of the breast tissue) or a breast conservation surgery. Due tothe use of widespread screening mammograms, women are diagnosed withlocalized and early-stage disease so that the breast conservationsurgery followed by radiation treatment may be used. The typicalradiation treatment is adjuvant breast radiation. While the adjuvantbreast radiation results in good survival rates, adjuvant breastradiation treatment typically takes 3.5 to 7 weeks which is too long. Inaddition, since the adjuvant breast radiation treatment is typicallyprovided using external beam radiation, there is a greater risk of acuteskin reactions due to the healthy tissue interaction with the radiation.

As a result, accelerated partial breast irradiation may be used whichresults in a quicker treatment time and less radiation-induced acuteskin reactions. One technique used for the accelerated partial breastirradiation is brachytherapy. In one method, radioactive sources arepermanently implanted into the breast tissue at the site of the surgerywherein the radioactive sources may be high dose or low dose.

Currently there are a handful of ways to insert radioactive sources intobreast tissue. One is by a free hand method, another uses a compressivetemplate device to temporary hold insertion catheters and the last usesa locking template system and non-fixated fiducial needle. These methodsare limited in that they do not ensure the sources are placed in thedesired location as prescribed by the treatment plan 100% of the time.The lack of ability to place the radioactive sources in the desiredlocation means that the remaining tumor margin is not receiving theappropriate radiation and healthy tissue is receiving unwantedradiation.

In the high dose rate brachytherapy area, a clinician would place hollowcatheters into the breast to facilitate the insertion of a temporaryradioactive source per a treatment plan which are then removed once thetreatment is completed. The placement of these catheters may be byeither free hand directly into the breast or by free hand thoughcompressive template systems used to stereo-tactically immobilize thebreast. Both Varian Medical Systems and Nucletron offer commerciallyavailable template immobilization products.

In the low dose rate brachytherapy area, one method for permanent breastradioactive seed implantation is described in detail in “First Report ofa Permanent Breast¹⁰³PD Seed Implant As Adjuvant Radiation Treatment forEarly-Stage Breast Cancer”, Dr. Jean-Philippe Pignol et al.,International Journal of Radiation Oncology Biological Physics, Vol. 64,No. 1, pp. 176-181 (2006) which is incorporated herein by reference.This method uses a non-fixated fiducial needle, locking template andstereotactic fixation to insert lose dose rate (LDR) radioactive sourcestrands into the treatment site. In this method, the fiducial needle canmigrate/move once inserted thus changing the depth at which the sourcestrands are deployed. In addition, the system is very cumbersome to useand is not user intuitive.

Thus, it is desirable to provide a mechanism to facilitate the insertionof radioactive sources/source strands into soft tissue, such as breasttissue and a method that utilizes this mechanism with the goal ofimproving the reproducibility of the procedure and ensuring that thesources are reliably and consistently inserted in an exact position pera patient prescription treatment plan from patient to patient as well asimprove the ease-of-use of the device and procedure. It is to this endthat the disclosure is directed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate a mechanism for adjuvant partial breastirradiation;

FIG. 2 illustrates a view of a breast with a tumor;

FIG. 3 illustrates a view of a breast with a tumor with a fiducialneedle inserted to accurately locate the tumor;

FIGS. 4A and 4B illustrate an example of a fiducial needle that can beused with the mechanism for adjuvant partial breast irradiation shown inFIGS. 1A and 1B;

FIG. 4C illustrates one technique for fiducial needle fixation;

FIG. 5 illustrates using an electromagnetic device for visualizing thefiducial needle shown in FIGS. 4A and 4B;

FIGS. 6A-6I illustrates examples of a fiducial needle with a retentiondevice that may be used with the mechanism for adjuvant partial breastirradiation shown in FIGS. 1A and 1B;

FIG. 7 illustrates an example of a fiducial needle fixation device thatmay be used with the mechanism for adjuvant partial breast irradiationshown in FIGS. 1A and 1B;

FIG. 8 illustrate more details of the template shown in FIG. 7;

FIGS. 9A and 9B illustrate an example of a locking pin of the templateshown in FIGS. 7 and 8;

FIG. 10 illustrate more details the locking pin shown in FIGS. 9A and9B;

FIG. 11 illustrates an assembled fiducial needle fixation device thatmay be used with the mechanism for adjuvant partial breast irradiationshown in FIGS. 1A and 1B;

FIGS. 12A and 12B are a cut-away view of the fiducial needle fixationdevice in an unlocked position;

FIG. 13 is a cut-away view of the fiducial needle fixation device in anlocked position;

FIGS. 14A-14C illustrate different examples of the fiducial needlefixation device with fiducial needles locked into the fiducial needlefixation device;

FIGS. 15A-15C illustrate the fiducial needle fixation device with lockedfiducial needles being inserted into the engagement device; and

FIG. 16 illustrates a method for adjuvant partial breast irradiationusing the fiducial needle fixation mechanisms.

DETAILED DESCRIPTION OF ONE OR MORE EMBODIMENTS

The disclosure is particularly applicable to low dose radioactive sourceimplantation into breast tissue and it is in this context that thedisclosure will be described. It will be appreciated, however, that themechanism and method has greater utility since the mechanism can be usedto implant various different radioactive sources into various differenttissues.

FIGS. 1A and 1B illustrate a mechanism 50 for adjuvant partial breastirradiation. The mechanism may include a table 52 on which a patientlies of their back to have the radioactive sources implanted into thesurgery cavity in their breast tissue following breast conservationsurgery. The mechanism may also include one or more well-known tableclamps 54 that are used to clamp one or more stereotactic armatures 56to the table and fix the stereotactic armatures relative to the table.Each stereotactic armature 56 may have joints that allow the position ofan operational end 59 of the armature to be adjusted and then fixedrelative to the table in three dimensions to form a fixed frame ofreference. The mechanism may further include a needle retraction stop 57attached to one stereotactic armature 56 and a fiducial needle fixationassembly 58 attached to another stereotactic armature 56 to form thefixed frame of reference.

As shown in FIG. 1B, the fiducial needle fixation assembly 58 mayfurther include an engagement device 60 that allows a fiducial needlefixation device 62 to be quickly and securely removably fixed to thestereotactic armature 56. Generally, the patient may lie on the tablewith the breast tissue against the fiducial needle fixation assembly 58so that one or more fiducial needles may be inserted into the breasttissue and the surgery cavity using an electromagnetic imaging system,such as for example ultrasound so that the surgeon can then accuratelyplace the one or more radioactive sources into the tumor bed/surgerycavity using an electromagnetic imaging system, such as for exampleultrasound to visualize the tumor bed/surgery cavity due to the one ormore fiducial needles as described below in more detail. In oneimplementation, the one or more radioactive sources may be ¹⁰³PD seedsand/or seed strands. The radioactive seeds may also be ¹²⁵I and or ¹³¹Cs

FIG. 2 illustrates a view of a breast 70 with a lumpectory site afterthe surgical removal of the tumor 72 (or surgery cavity when themajority of the tumor has been removed during breast conservationsurgery) and FIG. 3 illustrates a view of the breast 70 with thetumor/surgery cavity 72 with a fiducial needle 74 inserted to accuratelylocate the tumor/surgery cavity to allow the precise placement of theradioactive sources according to the treatment plan. In a process toplace one or more radioactive sources into the breast tissue/surgerycavity following the breast conservation surgery, there may be one ormore fiducial needles 74 inserted although only one fiducial needle 74is shown in FIG. 3 for illustration purposes. As described below, eachfiducial needle 74 may have one or more visualization features 76(described in more detail below with respect to FIGS. 4A and 4B) thatcan be seen when an electromagnetic source irradiates the breast tissueso that, based on the fiducial needles, the one or more radioactivesources can be precisely placed into the breast tissue according to atreatment plan to kill any tumor cells that were not removed during thebreast conservation surgery.

FIGS. 4A and 4B illustrate an example of a fiducial needle 74 that canbe used with the mechanism for adjuvant partial breast irradiation shownin FIGS. 1A and 1B. Each fiducial needle used in the adjuvant partialbreast irradiation shown in FIGS. 1A and 1B may have a shaft portion 78,a visualization portion 80 that has the one or more visualizationfeatures 76 and a tip portion 82. The fiducial needle may be constructedout of a rigid material and have an enhanced geometry that willfacilitate its fixation in the breast tissue. The shaft portion may beconstructed out of rod stock and may have a round, square, triangular,hexagonal or octagonal cross section. The fiducial needle may also havea retention features on the tip end that allows the needle to be easilyinserted and removed but, once in place, fixate the needle in itslocation by either tissue encapsulation into features of the needle (asshown in FIG. 4C and described below) or by penetration by either a userdeployable projection feature or similar structure as shown in FIGS.6A-6I which are described below. In one implementation, the overalloutside diameter of the needle shall be 15 gauge to 22 gauge (0.070″ to0.028″) and the needle may have a length of 3″ to 12″. The needle may bemanufactured out of stainless steel, stainless steel alloys including304, 316/316L, 321, 347, Inconel 624, 17-7ph, 430/434, Hastelloy C-276,Invar36, and or a polymer based material. The needle may have asharpened tip to facilitate easy penetration into tissue and the tip maybe trocar, pencil and or beveled in its point geometry.

As shown in FIG. 4B, the geometry of the needle may be optimized tofacilitate visualization with various clinical imaging modalities usingthe visualization features 76. Each visualization feature 76 may begeometry that is tailored to promote visualization under imaging. Forexample, each visualization feature 76 may further comprise topographicfeatures of elevated or depressed surface characteristics towards thetip of the needle that will help reflect the energy from an imagingsystem so that the position and orientation of the feature 76 and thefiducial needle can be accurately determined using the imaging system.In one implementation, each visualization feature 76 may include adepressed region 84 adjacent to an elevated region 86 as shown in FIG.4B.

FIG. 4C illustrates one technique for fiducial needle fixation intotissue 90. As shown in FIG. 4C, once the fiducial needle 74 is insertedinto the tissue 90, the tissue may move into the depressed regions 84(tissue encapsulation) which will cause the fiducial needle to betemporarily anchored into the tissue.

FIG. 5 illustrates using an electromagnetic device 92 for visualizingthe fiducial needle 74 shown in FIGS. 4A and 4B. The electromagneticdevice 92 may be an imaging device that generates electromagneticenergy. In one implementation, the electromagnetic device 92 may be anultrasound imaging device. The electromagnetic device 92 may also befluoroscopy, magnetic resonance imaging (MRI) and or computerizedtomography (CT) As shown, the electromagnetic device 92 generates energythat strikes the needle 74 and is reflected by the features 76 of theneedle as radiated energy 94 that is received by the electromagneticdevice 92 in order to precisely determine the position and orientationof the needle 74 relative to the electromagnetic device 92 (and hencethe precise position and orientation of the tumor/surgery cavity intowhich the radioactive sources may be implanted during the treatment.

FIGS. 6A-6I illustrates examples of a fiducial needle 74 with aretention device 98 that may be used with the mechanism for adjuvantpartial breast irradiation shown in FIGS. 1A and 1B. These figures showa plurality of different examples of a retention device 100, such as auser deployable and retractable barb feature (a user deployableprojection) that can be used to fixate the fiducial needle once it ispositioned so that the position of the fiducial needle relative to thebreast tissue and the mechanism shown in FIGS. 1A and 1B does not changeduring the procedure to insert the one or more radioactive sources intothe breast tissue so that the position of the one or more radioactivesources is precisely controlled. Any of the different examples shown inthese figures may also be combined together. Now, the fiducial needlefixation device 62 is described in more detail.

FIG. 7 illustrates an example of the fiducial needle fixation device 62that may be used with the mechanism for adjuvant partial breastirradiation shown in FIGS. 1A and 1B. In one implementation, thefiducial needle fixation device 62 may comprise an attachment balldevice 100, a fiducial needle lock 102, a template 104 and a locking pin106 that when attached to each other, lock one or more fiducial needlesinto the template 104 and rigidly secure the template to the attachmentball device 100 which in turn is rigidly connected to the stereotacticarmature. To lock the one or more fiducial needles into the template 104at one or more fiducial needle locations 108 of the template, the one ormore fiducial needles are inserted into the one or more fiducial needlelocations 108 with the locking pin 106 in an unlocked position and thenthe fiducial needle lock 102 is tightened to a locked position using aset of threads 110 on the locking pin which causes the locking pin 106to be pulled towards the fiducial needle lock 102 which moves thelocking pin into a locking position as will be described below in moredetail. Alternatively, the fiducial needle lock 102 may move from theunlocked position to the locked position using other mechanisms insteadof the set of threads.

In the fiducial needle fixation device 62, the locking of the fiducialneedles into a position does not affect any needles in the other holesof the template (holes A0-A9 through L0-L9) so that those needles (suchas needles that deliver the radioactive sources into the treatment site)are not locked into a position. Once the fiducial needles are lockedinto position, the attachment ball device 100 may be screwed into aninner set of threads of the locking pin (as shown in FIG. 9B) to providea rigid but alterable attachment of the template to the attachment balldevice 100 so that the attachment ball device may be inserted into theengagement device 60 of the mechanism as shown in FIGS. 1A and 1B.Alternatively, the attachment ball device 100 may be attached to thefiducial needle fixation device 62 by a locking mechanism instead of theset of threads.

FIG. 8 illustrate more details of the template 104 shown in FIG. 7. Inone example, the template is a solid/hollow rectangular shaped piece ofmaterial (although the template can be other shapes and sizes toaccommodate differing tumor/patient sizes) that has the lockablefiducial needle locations 108 as well as the other needle holes that arenot lockable as described above. Once the one or more fiducial needlesare locked into position and the fiducial needle fixation device 62 islocked into position relative to the mechanism 50, the needles with theradioactive sources can be inserted into the template holes at preciselyknown locations to insert and implant the radioactive sources into thebreast tissue according to the coordinated locations of the prescriptiontreatment plan.

FIGS. 9A and 9B illustrate an example of the locking pin 106 of thetemplate shown in FIGS. 7 and 8 and FIG. 10 illustrate more details thelocking pin 106 shown in FIGS. 9A and 9B. The locking pin 106 has theset of outer threads 110 that mesh with the fiducial needle lock 102 totighten the locking pin from an unlocked position to a locked positionas described below. The locking pin 106 may also have a stop 114 thatstops the end of the locking pin opposite of the threads 110 and lock itagainst the end of the template 104 as shown in FIG. 11. The locking pin106 also comprises one or more fiducial needle holes 116 (located alonga center of the locking pin 106 in one implementation as shown in FIG.9A) that, when the locking pin is in the unlocked position, the one ormore fiducial needles pass through the locking pin. When the locking pinis in the locked position (as shown in FIG. 13), the sides of thefiducial needle holes 116 are pressed against the side of the one ormore fiducial needles to lock the fiducial needle position relative tothe template. The locking pin 106 may also have a plurality of needleholes 118 that are slightly larger in diameter than the fiducial needleholes 116 so that, whether the locking pin 106 is in the locked orunlocked position, the locking pin does not lock the needles at anytime. As shown in FIGS. 9B and 10, the locking pin 106 may also includea set of internal threads 112 into which the threads of the attachmentball device 100 are threaded to secure the template and locking pin tothe attachment ball device 100.

FIG. 11 illustrates an assembled fiducial needle fixation device 62 thatmay be used with the mechanism for adjuvant partial breast irradiationshown in FIGS. 1A and 1B. In the assembled state with the locking pintightened so that the stop 114 is against the side of the template 104and the fiducial needle lock 102 is tightened and the attachment balldevice 100 is secured to the fiducial needle fixation device 62.

FIGS. 12A and 12B are a cut-away view of the fiducial needle fixationdevice in an unlocked position for a different number of fiducialneedles wherein the template 104 has the locking pin 106 inserted. Inthe unlocked position as shown in FIGS. 12A and 12B, the fiducial needlelocations 108 of the template are aligned with the fiducial needle holes116 of the locking pin 106 so that the fiducial needle 74 does not haveits position locked relative to the template 104 and the fiducial needlecan be slid though the template 104 to properly position the fiducialneedle relative to the template. FIG. 13 is a cut-away view of thefiducial needle fixation device 62 in an locked position. In the lockedposition, the locking pin 106 is tightened so that the fiducial needlelocations 108 of the template are not aligned with the fiducial needleholes 116 of the locking pin 106 so that the sides of the fiducialneedle holes 116 press against the side of a fiducial needle to lock thefiducial needle position relative to the fiducial needle fixation device62. When the fiducial needle position is locked relative to the fiducialneedle fixation device 62, the surgeon can precisely implant radioactivesources into the tissue.

FIGS. 14A-14C illustrate different examples of the fiducial needlefixation device 62 with fiducial needles 74 locked into the fiducialneedle fixation device. In particular, the fiducial needle fixationdevice 62 with four fiducial needles locked into the fiducial needlefixation device, three fiducial needles locked into the fiducial needlefixation device and one fiducial needle locked into the fiducial needlefixation device as shown. Thus, the fiducial needle fixation devicepermits one or more (up to five in the implementation shown) to belocked into the fiducial needle fixation device. However, the fiducialneedle fixation device may also be constructed to allow additionalfiducial needles to be positioned and locked into the fiducial needlefixation device.

FIGS. 15A-15C illustrate the fiducial needle fixation device 62 withlocked fiducial needles 74 being inserted into the engagement device 60.The engagement device 60 may comprise a head portion 120 that is rigidlyattached to the stereotactic armature 56 wherein the head portion has asocket region 122. As shown in FIGS. 15A and 15B, the ball of theattachment ball device 100 can be quickly inserted into the socketregion 122 to secure the fiducial needle fixation device 62 fixedly tothe stereotactic armature 56, but allow the fiducial needle fixationdevice 62 to also be rapidly removed from the engagement device 60 asneeded.

FIG. 16 illustrates a method 130 for adjuvant partial breast irradiationusing the fiducial needle fixation mechanisms. The method described canbe implemented using the various devices and mechanisms described aboveand allow the surgeon to precisely implant radioactive sources into thetissue. In a first process 132, the one or more stereotactic armaturesare attached to the operating table as shown above in FIGS. 1A and 1B.Then, the patient is prepared for surgery as is well known (134). Foradjuvant partial breast irradiation treatment, the patient may have herarm above her head on the side of the breast to be treated. Next, thesurgeon or technician inserts one or more fiducial fixation needles,under guidance by a medical imaging technology, into the site (136) suchas the lumpectomy site when a breast cancer patient is being treated.Next, the fiducial needle fixation device is attached to the one or morefiducial needles (138) with the fiducial needle fixation device is theunlocked position. For the adjuvant partial breast irradiation, it isdesirable to have the fiducial needle fixation device positionedadjacent and touching the breast tissue. Once properly positioned, thefiducial needle fixation device is tightened into the locked position(140). The ball of the assembled and locked fiducial needle fixationdevice is slipped into the quick connect socket of the stereotacticarmature (142) to fix the fiducial needle fixation device with respectto the operating table and the patient. The armatures are then tightened(144) to immobilize the system. Once the system is immobilize (whichensures precise placement of the radioactive sources), the surgeon maybegin to insert the brachytherapy needles containing the radioactivesources and/or source strands through the template and into the patientper the previously determined coordinate locations of the prescriptiontreatment plan. Once the implantation of the radioactive sources iscompleted, the method is completed.

While the foregoing has been with reference to a particular embodimentof the invention, it will be appreciated by those skilled in the artthat changes in this embodiment may be made without departing from theprinciples and spirit of the invention, the scope of which is defined bythe appended claims.

The invention claimed is:
 1. A device, comprising: a needle lock thatlocks at least one fiducial needle relative to a fixed frame ofreference, each fiducial needle having a distal end with a surfaceadapted to locate and fixate tissue into which the at least one fiducialneedle is inserted and a sharpened tip portion and a proximal end beinginserted through a grid that fixates the at least one fiducial needle tothe fixed frame of reference; and the grid being attached to the needlelock, the grid having a plurality of fiducial needle holes along alongitudinal axis each having a grid needle lock through which the atleast one fiducial needle is inserted and locked, a plurality ofradioactive source needle holes located above the longitudinal axis anda plurality of radioactive source needle holes located below thelongitudinal axis, each radioactive source needle hole does not have agrid needle lock through which a radioactive source needle is capable ofbeing passed into the tissue fixated by the locked at least one fiducialneedle.
 2. The device of claim 1, wherein the needle lock locks aposition of the at least one fiducial needle relative to the grid whileallowing the radioactive source needle to freely slide relative to thegrid.
 3. The device of claim 2, wherein the needle lock furthercomprises an attachment ball device that threadably attaches to thegrid, a fiducial needle lock that attaches to the grid and wherein thegrid needle lock is capable of being tightened to lock the position ofthe plurality of fiducial needles relative to the grid.
 4. The device ofclaim 3 further comprising an engagement device that removably securesthe needle lock to the fixed frame of reference.
 5. The device of claim4, wherein the engagement device further comprises a socket portion andwherein the attachment ball device further comprises a ball portionwherein the ball portion is removably inserted into the socket portionto secure the needle lock to the fixed frame of reference.
 6. The deviceof claim 1, wherein the grid further comprises a parallelogram array ofthe radioactive source needle holes and wherein the plurality offiducial needle holes are along a center line of the grid.
 7. The deviceof claim 1, wherein each fiducial needle has a surface feature that isvisualized.
 8. The device of claim 7, wherein the surface featurefurther comprises a recessed portion and a raised portion along a shaftof each fiducial needle.
 9. The device of claim 7, wherein each fiducialneedle has a shaft portion and the shaft portion has one of a roundcross section, a square cross section, a triangular cross section, ahexagonal cross section and an octagonal cross section.
 10. The deviceof claim 1, wherein the surface of the at least one fiducial needlefurther comprises one or more user deployable projection that anchorseach fiducial needle into the tissue.
 11. The device of claim 1, whereinthe at least one fiducial needle further comprises one or more depressedregions on the at least one fiducial needle configured to receivetissue.
 12. A device, comprising: a needle lock that locks at least onefiducial needle relative to a fixed frame of reference, each fiducialneedle having a distal end with a surface adapted to locate and fixatetissue into which the at least one fiducial needle is inserted and aproximal end being inserted through a grid that fixates the at least onefiducial needle to the fixed frame of reference; the grid being attachedto the needle lock, the grid having a plurality of fiducial needle holeseach having a grid needle lock through which the at least one fiducialneedle is inserted and locked and a plurality of radioactive sourceneedle holes that do not have a grid needle lock through which aradioactive source needle is capable of being passed into the tissuefixated by the locked at least one fiducial needle; and wherein theneedle lock locks a position of the at least one fiducial needlerelative to the grid while allowing the plurality of radioactive sourceneedles to freely slide relative to the grid and further comprises anattachment ball device that threadably attaches the grid, a fiducialneedle lock that attaches to the grid and wherein the grid needle lockis capable of being tightened to lock the position of the plurality offiducial needles relative to the grid, and wherein the grid needle lockfurther comprises a locking pin having a set of fiducial needle holesthrough the locking pin wherein a side of each fiducial needle hole ispressed against the at least one fiducial needle passing through theneedle lock when the locking pin is in a locked position, a set ofradioactive source needle holes through the locking pin, a set of outerthreads that cooperate with the fiducial needle lock to move the lockingpin between an unlocked position and the locked position, and a set ofinner threads that cooperate with the attachment ball device to attachneedle lock to the fixed frame of reference.